Pirfenidone Cipla

Package leaflet: Information for the user

Pirfenidone Cipla 267 mg film-coated tablets, 801 mg film-coated tablets

Pirfenidone
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Pirfenidone Cipla is and what it is used for
2. What you need to know before taking Pirfenidone Cipla
3. How to take Pirfenidone Cipla
4. Possible side effects
5. How to store Pirfenidone Cipla
6. Contents of the pack and other information

1. What Pirfenidone Cipla is and what it is used for

Pirfenidone Cipla contains the active substance pirfenidone and is used for the treatment of idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF) in adults.
IPF is a disease in which lung tissues become inflamed and damaged over time, making it difficult to breathe deeply. This impairs the proper functioning of the lungs. Pirfenidone Cipla helps reduce lung damage and inflammation, and helps improve breathing.

2. What you need to know before taking Pirfenidone Cipla

Do not take Pirfenidone Cipla

• if you are allergic to pirfenidone or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue, which may be associated with difficulty breathing or wheezing
• if you are taking a medicine called fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD])
• if you have severe or end-stage liver disease
• if you have severe or end-stage kidney disease requiring dialysis.

If any of the above conditions apply to you, do not take Pirfenidone Cipla. If in doubt, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pirfenidone Cipla

• you may become more sensitive to sunlight (photosensitivity reaction) while taking Pirfenidone Cipla. Avoid sun exposure (including sunlamps) during treatment with Pirfenidone Cipla. Apply sunscreen daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects).
• do not take other medicines, such as tetracycline antibiotics (e.g. doxycycline), which may increase your sensitivity to sunlight.
• if you have kidney problems, inform your doctor.
• if you have mild to moderate liver problems, inform your doctor.
• you must stop smoking before and during treatment with Pirfenidone Cipla. Cigarette smoking may reduce the effect of Pirfenidone Cipla.
• Pirfenidone Cipla may cause dizziness and fatigue. Be cautious if performing activities requiring mental alertness and coordination.
• Pirfenidone Cipla may cause weight loss. Your doctor will monitor your weight during treatment with this medicine.
• cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with pirfenidone treatment. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop treatment with Pirfenidone Cipla and seek immediate medical advice.

Pirfenidone Cipla can cause serious liver problems, which in some cases have been fatal. You will need to have a blood test before starting Pirfenidone Cipla, monthly for the first 6 months, and then every 3 months during treatment to monitor proper liver function. It is important that you attend these regular blood tests while taking Pirfenidone Cipla.
Children and adolescents
Do not give Pirfenidone Cipla to children and adolescents under 18 years of age.
Other medicines and Pirfenidone Cipla
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking the following medicines, as they may alter the effect of Pirfenidone Cipla.
Medicines that may increase the side effects of Pirfenidone Cipla:

• enoxacin (a type of antibiotic)
• ciprofloxacin (a type of antibiotic)
• amiodarone (used to treat certain heart conditions)
• propafenone (used to treat certain heart conditions)
• fluvoxamine (used to treat depression and obsessive-compulsive disorder [OCD])

Medicines that may reduce the effectiveness of Pirfenidone Cipla:

• omeprazole (used to treat conditions such as indigestion, gastroesophageal reflux disease)
• rifampicin (a type of antibiotic).

Pirfenidone Cipla with food and drink
Do not drink grapefruit juice while taking this medicine. Grapefruit may interfere with the proper action of Pirfenidone Cipla.
Pregnancy and breastfeeding
As a precautionary measure, it is preferable to avoid using Pirfenidone Cipla during pregnancy, or if you suspect you might be pregnant or are planning a pregnancy, since the potential risks to the fetus are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before taking Pirfenidone Cipla. Since it is not known whether Pirfenidone Cipla passes into breast milk, your doctor will evaluate the risks and benefits of taking this medicine during breastfeeding if you decide to breastfeed.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or fatigue after taking Pirfenidone Cipla.
Pirfenidone Cipla contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Pirfenidone Cipla

Treatment with Pirfenidone Cipla must be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of idiopathic pulmonary fibrosis (Idiopathic Pulmonary Fibrosis - IPF).
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The medicine will usually be administered in gradually increasing doses as follows:

• for the first 7 days, take a dose of 267 mg (1 yellow tablet) three times a day with food (total daily dose: 801 mg)
• from day 8 to day 14, take a dose of 534 mg (2 yellow tablets) three times a day with food (total daily dose: 1602 mg). A dose of 534 mg will be achieved by taking two 267 mg yellow tablets.
• from day 15 onwards (maintenance phase), take a dose of 801 mg (3 yellow tablets or 1 pink tablet) three times a day with food (total daily dose: 2403 mg).

The recommended daily maintenance dose of Pirfenidone Cipla is 801 mg (3 yellow tablets or 1 pink tablet) three times a day with food, for a total daily dose of 2403 mg.
Swallow the tablet whole with water during or after meals to reduce the risk of side effects such as nausea and dizziness. If symptoms persist, consult your doctor.
Dose reduction due to side effects
Your doctor may reduce your dose if you experience side effects such as stomach problems, skin reactions to sunlight or sunlamps, or significant changes in liver enzymes.
If you take more Pirfenidone Cipla than you should
If you have taken more tablets than prescribed, contact your doctor, pharmacist, or nearest emergency department immediately and bring the medicine with you.
If you forget to take Pirfenidone Cipla
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose. There must be at least three hours between doses. Do not take more tablets in one day than prescribed according to the recommended daily dose.
If you stop taking Pirfenidone Cipla
In certain specific cases, your doctor may advise you to stop taking Pirfenidone Cipla.
If you need to stop treatment with Pirfenidone Cipla for more than 14 consecutive days for any reason, your doctor will restart treatment with a dose of 267 mg three times a day, gradually increasing the dose up to 801 mg three times a day.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Pirfenidone Cipla and seek immediate medical help if you notice any of the following symptoms or signs:

• Swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or shortness of breath, or feeling faint. These are symptoms of angioedema, a severe allergic reaction or anaphylaxis.
• Yellowing of the whites of the eyes or skin, or dark urine, possibly accompanied by skin itching, pain in the upper right part of the stomach (abdomen), loss of appetite, increased tendency to bleed or bruise, or feeling tired. These may be signs of impaired liver function and could indicate liver damage, which is an uncommon side effect of Pirfenidone Cipla.
• Flat, red spots or circular rashes on the trunk, often with central blisters, peeling skin, or sores in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread skin reaction, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other side effects may include
Talk to your doctor if you notice any side effect.
Very common (may affect more than 1 in 10 people):

• Throat or lower respiratory tract infections and/or sinusitis
• Feeling unwell (nausea)
• Stomach problems such as acid reflux, vomiting, and constipation
• Diarrhoea
• Indigestion or stomach discomfort
• Weight loss
• Reduced appetite
• Difficulty sleeping
• Tiredness
• Dizziness
• Headache
• Shortness of breath
• Cough
• Arthralgia/joint pain

Common (may affect up to 1 in 10 people):

• Bladder infections
• Drowsiness
• Taste disturbances
• Hot flushes
• Stomach problems such as bloating, pain and abdominal discomfort, heartburn, and passing gas
• Blood tests may show increased liver enzyme levels
• Skin reactions after exposure to sunlight or use of sunlamps
• Skin problems such as itching, redness, dry skin, rash
• Muscle pain
• Feeling weak or lacking energy
• Chest pain
• Sunburn

Uncommon (may affect up to 1 in 100 people):

• Low sodium levels in the blood, which may cause headache, dizziness, confusion, weakness, muscle cramps, or nausea and vomiting
• Blood tests may show a reduction in white blood cells

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Pirfenidone Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pirfenidone Cipla contains

• The active substance is pirfenidone.
  • 267 mg tablet: Each film-coated tablet contains 267 mg of pirfenidone.
  • 801 mg tablet: Each film-coated tablet contains 801 mg of pirfenidone.
• The other components are:
  • tablet core: Anhydrous colloidal silica (E551), hypromellose (E464), mannitol (E241), sodium starch glycolate (Type A), and sodium stearate fumarate
  • film coating: Macrogol (E1521), polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171). The 267 mg film-coated tablet also contains yellow iron oxide (E172). The 801 mg film-coated tablet also contains red iron oxide (E172).

Description of the appearance of Pirfenidone Cipla and contents of the pack
267 mg tablet
The 267 mg film-coated tablets of Pirfenidone Cipla are yellow to light yellow in colour, biconvex, oval-shaped with bevelled edges, film-coated, and have no inscription on either side. The tablet size is approximately 14 mm x 7 mm.
Starting treatment pack for 2 weeks: multipack containing 63 film-coated tablets (1 pack of 21 and 1 pack of 42).
63 (3 blisters of 21) film-coated tablets
84 film-coated tablets
Maintenance pack: multipack containing 252 film-coated tablets (3 packs of 84).

84 film-coated tablets
Maintenance pack: multipack containing 252 film-coated tablets (3 packs of
84).
The blister strips are marked with the following symbols and abbreviated day names, as a reminder to take a dose three times daily.

MON. TUE. WED. THU. FRI. SAT. SUN.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Cipla Europe NV
De Keyserlei 60C, Bus-1301
2018 Antwerp, Belgium
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Sweden Pirfenidon Cipla
Belgium Pirfenidon Cipla
Germany Pirfenidon Cipla
Spain Pirfenidona Cipla
Norway Pirfenidon Cipla
France Pirfenidone Cipla
Italy Pirfenidone Cipla
Poland Pirfenidon Cipla
Ireland Pirfenidone Cipla
Finland Pirfenidon Cipla